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Идёт набор NCT07608003

Multicenter Prospective Study on MRI AI Model for Midline Glioma Subtyping and Prognosis:

Наблюдательное Gliomas Harboring IDH1 and/or IDH2 Mutations Glioma Glioblastoma Multiforme Glioma of Brainstem Glioma, Diffuse Midline, H3K27M-mutant

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Gliomas Harboring IDH1 and/or IDH2 Mutations, Glioma Glioblastoma Multiforme, Glioma of Brainstem, Glioma, Diffuse Midline, H3K27M-mutant. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Application of MRI-Based Artificial Intelligence Models for Preoperative Molecular Subtyping and Prognostic Assessment of Midline Gliomas: A Multicenter Prospective Clinical Study

Обзор

A vision-language model using preoperative MRI and clinical variables has been developed to simultaneously predict three key molecular markers in midline gliomas: H3K27M, IDH, and 1p/19q. This prospective multicenter study will validate the model's accuracy in preoperative molecular subtyping and its value in prognostic assessment and clinical decision-making across multiple neurosurgical centers.

Подробное описание

This study aims to validate the clinical value of an MRI-based artificial intelligence model for personalized diagnosis and treatment in patients with midline gliomas. The model integrates preoperative MRI features with clinical variables (e.g., age, sex, and other relevant patient characteristics) to predict both molecular subtypes and patient prognosis.

Model workflow. The model takes as input tumor-containing slices from preoperative MRI sequences, along with patient age and sex. By recognizing information within the MRI sequences, the model outputs the predicted molecular diagnosis for the patient.

Primary objective. To evaluate the model's accuracy in preoperative molecular subtyping of midline gliomas (H3K27M, IDH, and 1p/19q status) by comparing its predictions with the gold standard of postoperative or post-biopsy pathology. Diagnostic performance will be assessed using sensitivity, specificity, accuracy, F1 score, and area under the receiver operating characteristic curve (AUC).

Secondary objective. To assess the model's prognostic capability by integrating imaging features with clinical variables to predict patient survival outcomes and treatment response. Prognostic performance will be evaluated using time-dependent AUC and calibration metrics.

Exploratory objective. To explore the model's added value in clinical decision-making, including its potential to guide preoperative treatment planning and risk stratification.

This prospective, multicenter study will be conducted across several tertiary neurosurgical centers in China. The findings are expected to provide high-level evidence supporting non-invasive, precise diagnosis and personalized management of midline gliomas.

Первичные конечные точки

  • Diagnostic accuracy for midline glioma molecular subtypes [Срок оценки: Perioperative]

Критерии участия

Критерии включения

  • Patients with diffuse gliomas were pathologically and molecularly diagnosed.
  • The clinical case data of all patients were complete.
  • Patients underwent preoperative MRI examination.

Критерии исключения

  • The tumor is not located in the intracranial midline.
  • Cases in which MRI were incomplete or with significant noise and artifacts.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Китай · 1 центр
  • Xiangya Hospital of Central South University — Чанша

Идентификаторы

NCT: NCT07608003 · 2026040726

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗